A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body

What Was Tested

In this phase 1 trial, researchers set out to test Survodutide.

The main objective of this trial is to investigate relative bioavailability of BI 456906 formulation B and BI 456906 formulation C vs.

It had three arms (groups): Treatment sequence R-T2-T1 (experimental), Treatment sequence T1-R-T2 (experimental) and Treatment sequence T2-T1-R (experimental).

T1: BI 456906 formulation B T2: BI 456906 formulation C R: BI 456906 formulation A.

The registry classes the interventions as combination product and drug.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age of 18 to 55 years (inclusive). Body mass index (BMI) of 20 to 29.9 kg/m² (inclusive). Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator; any laboratory value outside the reference range that the investigator considers to be of clinical relevance; any evidence of a concomitant disease assessed as clinically relevant by the investigator.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Survodutide and who got the comparison, which limits bias.

Each person switched between Survodutide and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Survodutide study: the participants and staff both knew the treatment.

It started in 2025-02-10 with completion listed for 2025-05-29.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) (time frame: Up to 22 days). Maximum measured concentration of the analyte in plasma (Cmax) (time frame: Up to 22 days).

It also tracked 1 secondary outcome, for example Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Survodutide in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Survodutide compound page, all human trials.